SPECIALIST QUALITY

QC Chemist

POSITION SUMMARY : Prioritize daily sample testing and perform a variety of laboratory tests on raw materials, in-process and finished batches.

Review compounding and laboratory records for accuracy and completeness. Investigate customer complaints, OOS / OOT results and implement any corrective action as determined by QC supervision.

Aid in training new Associates.

Essential Functions

• Behavior : Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts
• Attendance / Punctuality : Presence at work on time when scheduled is a mandatory function
• Safety : Compliance with all company safety rules, procedures, and guidelines is mandatory
• Perform laboratory analysis on incoming raw materials, in-process samples, and finished products per established procedures, including wet chemistry, GC & HPLC
• Prepare samples for chromatographic analysis, prepare standard and reagent solutions
• Maintain company standards of sanitation and safety
• Sample raw materials per approved procedures
• Coordinate information flow within the laboratory and to internal customers
• Access, input, and retrieve information from the QC computer systems
• Disposition of raw materials, process samples and finished products for use or sale
• Be thoroughly versed in GMP regulations and ensure that all laboratory documentation meets standards for completeness and accuracy
• Demonstrate a complete understanding of safe procedures for processing, analyzing, and storage of hazardous, flammable and raw materials in accordance with local, state, and federal guidelines
• Record deviations in performance not anticipated or indicated in test procedures
• Learn and follow QC and manufacturing processes and work flows, QC retain program and documentation procedures
• Work with minimal supervision, re-prioritizing work schedules quickly
• Proficient in performing routine GC and HPLC analysis including integration and result calculations
• Knowledgeable of OOS / OOT and Customer complaint investigations
• Become familiar and assist with Method Development Protocols and conduct requisite testing
• Become familiar and assist with IQ / OQ / PQ and instrument validation / calibration tasks
• Become familiar and assist with Method Transfer protocols and requisite testing
• Participate in Annual / New Supplier Validations protocol, sample transfer and testing process
• Become familiar and assist with SOP creation, review and revision activities
• Ensure Stability protocols and testing processes are adhered too
• Understand and complete supplies / services ordering
• Perform contract manufacturing protocols and work flows
• Knowledge of lab instrument maintenance and troubleshooting
• Ability to perform any routine task in the laboratory in an efficient manner
• Provide timely, accurate information to production personnel
• Attend meetings as required
• Complete required training
• Other duties as assigned

Physical Activities : Walking, talking, hearing, climbing, balancing, reaching, grasping, standing, and stooping.

Physical Demands : Occasionally lift boxes of product 5-40 lb. Frequently lift samples 1-5 lb.

Visual Acuity : Clarity of vision at 20 inches or less, with the ability to distinguish colors and adjust eye to bring objects into sharper focus.

Environmental / Atmospheric Conditions : Worker exposed to extreme heat and cold with temperatures sufficiently high or low to cause marked bodily discomfort.

Exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Worker exposed to hazards such as proximity to moving mechanical parts.

Works in laboratory, production line and warehouse environments.

POSITION QUALIFICATION REQUIREMENTS :

Knowledge : Requires BS / BA degree in Chemistry or related science and thorough understanding of FDA regulations. Education may be offset by progressively responsible experience.

Also requires thorough working knowledge of laboratory and / or test procedures. Ability to use laboratory equipment in a safe, efficient manner.

Experience : Requires 1-2 years of progressive Quality Control experience, with proficiency in a laboratory environment.

Demonstrated interpersonal skills are vital. Must be able to work well independently and make quick decisions under pressure.

Requires a minimum of 5 years ViJon specific QC experience when degree requirement is not met.

Machines, Tools, Equipment and Work Aids : Computer & related programs, laboratory glassware, sampling equipment, chemical reagents, pH meter, viscometer, balance, TOC, Densitometer, HPLC, GC, FT-IR, Federal Register, and standard office equipment.

License(s) / Certification(s) Required : None identified